Litigation Details for CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA (D. Del. 2019)

CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA (D. Del. 2019)

Docket	1:19-cv-00956	Date Filed	2019-05-23
Court	District Court, D. Delaware	Date Terminated	2021-06-10
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Patents	8,410,077; 9,200,088; 9,493,582
Link to Docket	External link to docket

Details for CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-05-23				External link to document
2019-05-23	1	Complaint	and lawfully issued United States Patent No. 9,200,088 (“the ’088 patent”), entitled “Sulfoalkyl Ether … COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 9,200,088 26. CyDex realleges and incorporates…and interest in the ’088 patent and the ’582 patent (collectively, “the patents-in-suit”). … 1. This is an action for patent infringement under the patent laws of the United States arising…. This is an action for patent infringement arising under the Patent Laws of the United States,	External link to document
2019-05-23	122	Opinion - Memorandum Opinion	infringement of an additional patent, U.S. Patent No. 8,410,077 (the 077 patent”) (D.I. 41 Ex. C). (See generally…of U.S. Patent Nos. 9,200,088 (the “088 patent”) (D.I. 1 Ex. A); and 9,493,5 82 (the “582 patent”) (D.I…. “It is a bedrock principle of patent law that the claims of a patent define the invention to which the…reading the entire patent.” fd. at 1321 (internal quotation marks omitted). The patent “specification is….” (582 patent at 6:19-34) The Court’s construction | This term appears in the 088 patent at claims	External link to document
2019-05-23	149	~Util - Terminate Civil Case AND Order	States Patent Nos. 8,410,077, 9,200,088, and 9,493,582 (collectively, the "CyDex Patents")…States or with respect to any patent other than the CyDex Patents. 10. For purposes of…JUDGMENT AND DISMISSAL ORDER This action for patent infringement (the "Litigation") has been… § 355(j)(2)(A)(vii)(IV) directed to the CyDex Patents and seeking approval to market a generic melphalan…injection prior to the expiration of the CyDex Patents. CyDex and Alembic have agreed to enter	External link to document
2019-05-23	39	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,410,077 B2 (First Amended Complaint…2019 10 June 2021 1:19-cv-00956 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-05-23	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,200,088 B2 ;9,493,582 B2. (…2019 10 June 2021 1:19-cv-00956 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-05-23	41	Complaint - Amended	COUNT III FOR INFRINGEMENT OF U.S. PATENT NO. 8,410,077 45. CyDex realleges and …interest in the ’088 patent, the ’077 patent, and the ’582 patent (collectively, “the patents-in-suit”). … 1. This is an action for patent infringement under the patent laws of the United States arising…. This is an action for patent infringement arising under the Patent Laws of the United States, … THE PATENTS-IN-SUIT 18. On December 1, 2015, the United States Patent and Trademark	External link to document

Litigation summary and analysis for: CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA (D. Del. 2019)

Last updated: June 15, 2026

CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA (1:19-cv-00956): Litigation Summary, Status, and Patent Exposure Analysis

CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA, No. 1:19-cv-00956, is a US Hatch-Waxman patent infringement case filed in the District of Delaware in 2019. The matter is tied to CyDex’s branded drug portfolio and Alembic’s US generic regulatory pathway, with the litigation posture and ultimate patent-handling outcome governed by the ANDA/Paragraph IV framework and the court’s case-management and scheduling orders.

What follows is the litigation summary and analysis based on the docket identifier you provided (1:19-cv-00956).

What patents were asserted in CyDex Pharmaceuticals v. Alembic Global Holding SA (1:19-cv-00956)?

Direct outcome: No complete asserted-patent list is available from the information provided in the prompt alone.

What is typically asserted in a Hatch-Waxman case like this

In Paragraph IV ANDA litigations in Delaware, the plaintiff typically asserts:

• One or more Orange Book-listed US patents covering the drug substance, formulation, or method of use
• Claims tied to the specific dosage form and label described in the ANDA
• A subset of claims after pleadings, often narrowed through claim construction and later summary judgment

Case-specific asserted patents: Not specified in the provided input.

When was the case filed and what procedural milestones matter (1:19-cv-00956)?

Direct outcome: The filing year (2019) is implied by the docket number year, but exact procedural milestones (complaint filing date, answer date, motions, hearings, and claim construction dates) are not stated in the provided input.

Milestones that drive settlement vs trial in ANDA cases

Even without the dates, the high-value timeline elements for assessing resolution are:

• Complaint filing and service
• ANDA technical and non-infringement contentions from the ANDA filer (Alembic)
• Invalidity contentions and expert discovery scope
• Markman/claim construction schedule
• Summary judgment or stipulated dismissal events
• Consent judgment / covenant-not-to-sue
• Final judgment triggering or preserving generic launch timing

Case-specific milestone dates: Not available from the prompt.

What is the Delaware docket posture: stayed, settled, dismissed, or tried?

Direct outcome: The prompt provides only the case caption and docket number; it does not provide dispositive docket outcomes (dismissal, settlement, or final judgment).

How to interpret posture for exclusivity and entry risk

For business and licensing decisions, the posture determines:

• Whether Alembic was blocked until patent expiry
• Whether entry was enabled by settlement carve-outs, licensed rights, or judgment invalidating asserted claims
• Whether appeal risks remain and whether a final appellate mandate affects remaining enforcement

Case-specific posture: Not specified in the provided input.

How does a Paragraph IV ANDA litigation like 1:19-cv-00956 affect generic launch timing?

Direct outcome: Specific launch timing impact cannot be quantified without:

• the asserted patents and their expiration dates
• whether the court entered a final judgment
• whether a settlement created a launch date or “carve-out” period

Entry mechanics that determine timing

In typical Hatch-Waxman structure:

• Filing of an ANDA with a Paragraph IV certification triggers a statutory 30-month stay unless court decisions end the stay earlier.
• The stay can be shortened if the court finds invalidity or non-infringement, and can be extended by later filings or post-trial events.
• If the case settles, the settlement often sets a negotiated:
  • launch date
  • design-around conditions
  • exclusivity duration
  • royalty/licensing terms (sometimes)
  • dismissal with prejudice or entry of judgment

Case-specific timing impact: Not computable from the provided input.

Which parties besides CyDex and Alembic typically appear in this type of case (and what does it imply)?

Direct outcome: No additional parties are listed in the prompt.

Common involvement patterns

Depending on the portfolio, related entities may appear as:

• co-plaintiffs owning specific Orange Book patents
• co-defendants tied to manufacturing or ANDA labeling
• brand-law firms or generic counsel reflecting joint defense structures
• interested pharmaceutical manufacturers if contract manufacturing is implicated

Case-specific party list: Not available from the provided input.

What Orange Book status would likely govern this dispute, and what listings matter?

Direct outcome: The prompt does not identify:

• the specific CyDex-branded active ingredient
• the Orange Book patents in play

Orange Book listings that matter in infringement scope

In practice, the litigated Orange Book patents usually fall into:

• Drug substance process or polymorph patents
• Drug product formulation patents (composition, stabilizers, particle size, coatings)
• Method-of-use patents tied to dosing or therapeutic regimen
• Bioavailability or performance patents tied to the ANDA’s submitted BE profile

Case-specific Orange Book mapping: Not available from the provided input.

What is the patent strength profile implied by typical CyDex vs generic disputes?

Direct outcome: No asserted patent set or claim scope is provided, so no strength scoring can be calculated.

Strength metrics typically assessed

Patent strength for Hatch-Waxman cases is assessed by:

• claim breadth for infringement reach
• written description and enablement risk under §112
• prior art density for obviousness
• prosecution history estoppel and claim construction narrowness
• test of commercial reality (does the generic design around actually avoid claim scope?)

Case-specific patent strength: Not computable from the prompt.

What generic entry risks exist for Alembic if CyDex’s asserted claims are limited or dismissed?

Direct outcome: Without:

• asserted patents
• final judgment or dismissal terms
• any licensing or covenant structure
  the entry risk cannot be quantified.

Risk categories

For business planning, the key risk buckets are:

• Design-around success risk (whether Alembic’s proposed formulation or method avoids all surviving claims)
• Remaining asserted claim risk (even if some patents fall, others may remain enforceable)
• Appeal pendency risk (whether an appellate stay blocks entry)
• Enforcement risk (post-judgment infringement suits if the generic launches)

Case-specific entry risk: Not computable from the provided input.

Did CyDex and Alembic reach a settlement, and what settlement terms typically cover?

Direct outcome: The prompt does not provide settlement status or terms.

Settlement terms that drive enforceability and market timing

Settlement agreements in these cases usually address:

• scope and duration of permitted sales
• dismissal provisions
• license grants or covenants not to sue
• non-admission clauses
• confidentiality and dispute resolution
• carve-outs for potential future changes to labeling or manufacturing

Case-specific settlement details: Not available from the provided input.

What regulatory status would align with the litigation (FDA ANDA, labeling, and exclusivity)?

Direct outcome: The drug identity is not provided; therefore, FDA pathway details cannot be tied to the litigation.

What to map once the NDA/ANDA is identified

For a complete regulatory risk view, the mapping requires:

• ANDA submission date and application number
• Paragraph IV certification and patent numbers
• tentative approval timeline
• Orange Book expiration and any pediatric exclusivity or orphan exclusivity (if applicable)
• labeling carve-outs from settlement

Case-specific FDA status: Not available from the provided input.

How does the case compare with other CyDex generic challenges against Alembic or similar filers?

Direct outcome: No comparators or case list are provided.

What comparison typically reveals

Cross-case comparison typically identifies:

• repeat asserted patents across multiple generics
• whether CyDex uses broad formulation claims consistently
• whether defendants win on claim construction trends
• whether CyDex settlements cluster around common launch windows

Case-specific comparative analysis: Not computable from the prompt.

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Key Takeaways

• The docket identifier CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA, 1:19-cv-00956 identifies a 2019 Hatch-Waxman-style patent infringement dispute in Delaware, but the prompt does not provide the asserted patents, dates of dispositive orders, or final outcome required for a litigation-grade analysis.
• Without the Orange Book patent list and the court outcome, market entry timing, exclusivity impact, and patent strength cannot be quantified.
• Any business decision tied to Alembic’s generic exposure requires the asserted-patent set and the docket’s disposition, neither of which is included in the provided input.

FAQs

1. What is the typical legal framework for CyDex-style ANDA Paragraph IV cases in Delaware?
2. How do 30-month stays interact with settlement agreements in Hatch-Waxman litigation?
3. What claim categories (substance, formulation, method of use) most often determine claim construction outcomes?
4. How do appellate timelines affect generic launch if a district court decision is appealed?
5. What Orange Book data points most directly control the scope of infringement in ANDA cases?

References (APA)

1. CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA, No. 1:19-cv-00956 (D. Del. 2019).